RA/QA Project Manager (ADX-139-20) at ArcherDX
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RA/QA Project Manager (ADX-139-20)
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
POSITION SUMMARY:
The RAQA Project Manager will identify, organize and drive key initiatives within the quality domain. This role will help enable best-in-class performance from Archer’s quality & regulatory teams by tracking key deliverables, communicating priorities and anticipating obstacles. This position will complement the quality team’s skills with sharp organizational communication, planning, and transparency.
RESPONSIBILITIES:
- Organize and drive execution of key initiatives within the quality and regulatory functions
- Assist domain leaders with creating detailed plans for tracking critical workstreams, milestones and deliverables
- Standardize communications within the quality and regulatory departments, providing regular status and progress updates to Archer’s senior management and core teams
- Strategize with quality management for the balancing of competing priorities, challenging timelines, and resource deployment
- Assist with QC lab operations, scheduling and throughput planning
- Identify areas for improvement in quality and regulatory operations and deploy strategies that drive improvement
- Collaborate closely with the Project Management Office to ensure project managers possess accurate information on quality deliverables and initiatives
- Provide input on quality and regulatory dashboards for management review and external partners
- Be a visible proponent of quality culture within Archer
- Provide strategic quality and regulatory insight throughout the product development process and ensure strong domain representation in product development and manufacturing services teams
- Support investigations of laboratory and product issues to insure timely, closed loop corrective actions and reports as required
- Facilitate departmental team meetings by taking notes, tracking action items, issuing minutes and holding owners accountable
KEY ATTRIBUTES:
- Passion for enhancing healthcare outcomes with novel technology
- Problem solver comfortable operating in the grey-space and driving forward with risk balanced decision making
- Must exemplify Archer’s values: Accountability, Care, Trust, Grit & Urgency
- History of thriving in a fast-paced, dynamic environment
- Self-starter
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently
- Strong influence, leadership, and communication skills
EXPERIENCE:
- +2 Program/Project management
- +2 years in a medical technology discipline
- PMP certification strongly preferred
- Working knowledge of cGMP/CFR/ISO standards & FDA regulations preferred
- Proficiency in NGS, PCR, qPCR, and sample prep techniques strongly preferred
EDUCATION:
- Bachelor's degree in a technical discipline
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